Associate Director, Analytical Strategy
Core
Design and oversee analytical strategies supporting product development and lifecycle management for recombinant protein and gene therapy products.
Role type
Senior IC analytical strategy lead
Builds
Robust, compliant, and innovative analytical approaches across pre-clinical, clinical, and commercial phases
Domain
Biotechnology / Pharmaceutical R&D
Required skills
Analytical strategy design, regulatory guidance, method development and validation, data analysis, leadership, strategic program management, health authority interaction
Preferred skills
Gene therapy product experience
Technologies
Analytical platforms, regulatory submission tools
Responsibilities
Develop global analytical strategies aligned with program goals; Provide scientific and regulatory guidance for analytical plans; Drive innovation in analytical technologies and workflows; Review analytical study designs and regulatory documentation; Oversee development, validation, and implementation of analytical methods; Ensure high-quality data generation; Troubleshoot complex scientific challenges; Ensure compliance with global regulatory guidelines; Lead analytical sections of regulatory submissions; Maintain inspection readiness; Partner with internal stakeholders and external partners
Seniority
Senior, strategic leadership